Léa RIFFAUT

ANSES

PPP Coordination Unit

Experiences in the AIR III evaluation process

Feedback from ANSES

Purpose of this presentation

General aspects of the AIR III program

Basic guidances and regulatory aspects Overview process and timing for AIR III Allocation of AIR III dossiers for FR Worksharing with RMS or Co-RMS at ANSES

AS Renewal and Classification

AS Renewal and MRL

Difficulties and Challenges with AIR III

Conclusion

General aspects of the AIR III program

Some Basic Guidances and Regulatory Aspects

The procedure describing the implementation of the renewal for Active Substances under Reg. 1107/2009 is developped in Reg 844/2012 and detailed in GD SANCO/2012/11251.

Under AIR III program full implementation of Reg. 1107/2009 (approval criteria, « cut off » criteria and other criteria apply)

AIR III Active Substance dossiers must follow the New Data Requirements Reg. 283/2013 and 284/2013 apply

Procedural and technical GD noted at the time of submission of the dossier must be used for the assessment

RMS shall prepared a standalone Renewal Assessment Report (RAR) under the New DAR Template (Doc SANCO/12592/2012)

Overview process and timing for AIR III

Allocation of AIR III dossiers for FR

According to Reg. 686/2012 allocating the actives substances to RMS and Co-RMS, ANSES (FR) is involved in the assessment of 28 AIR dossiers Important workload

Worksharing with RMS or Co-RMS at ANSES

Role of Co-RMS is not especially defined in GD SANCO/2012/11251 but 2 options can be proposed as reviewer only or writer of some parts

Considering ANSES workload in the AIR III program we follow the principles:• Sole writer of the RAR when we are RMS•Only reviewer of the RAR when we are Co-RMS

As RMS, we inform the Co-RMS, as far as possible, of our progress and potential issues on the evaluation

AS Renewal and Classification

AS Renewal and Classification

As mentioned in the GD on renewal procedure (SANCO/2012/11251), if it is

considered necessary, a revised proposal for classification & labelling should be submitted

to ECHA in parallel with the procedure of renewal of the AS

Necessity to align procedures under Reg. 844/2012 and Reg. 1272/2008

Experience so far as RMS in dealing with AIR and classification

Up to now, among the AIR III dossiers received so far, ANSES identified :

• 1 AS that needs a harmonised classification

• 2 AS that would need a potential revision of the current classification. For these cases, we focus on AS suspected to be CMR Category 1A, 1B or 2

This is discussed during pre-submission meetings and in these cases ANSES request applicant to submit:

• for a harmonised classification a « light » IUCLID dossier (Identity part - 1.1; 1.2; 2.1) and to prepare a full draft CLH report

• for potential revision of classification, an updated CLH dossier including a draft CLH report focussing only on these aspects

AS Renewal and Classification

AS Renewal and MRL

AS Renewal and MRL

COM confirmed that the procedure foreseen in Art. 12(1) of Reg. 396/2005 is not applicable following the renewal of an AS

According to the GD on renewal procedure (SANCO/2012/11251), it is strongly recommended that applicants should submit all MRLs applications which they considered necessary for extension of uses or possible amendment of existing MRLs (not only those relevant to the representative uses)

AS Renewal and MRL

RAR prepared by RMS, includes where relevant and necessary, a proposal to set new MRLs or modify existing ones. A notification is sent to EFSA at the same time of RAR release.

MRL proposals are considered during the EFSA Peer Review

EFSA conclusion includes both evaluation of AS renewal and MRL application

Difficulties and Challenges with AIR III

Difficulties and Challenges with AIR III

Heavy workload within very short timelines

Not always easy to deal with when RMS changes from first approval

Sometimes difficult to plan the reviewing work when we are Co-RMS Smooth communication between RMS and Co-RMS is important to cope with this

Difficulties and Challenges with AIR III Sometimes difficult to have access to the old

dossier submitted for first approval under an exploitable format

AIR III dossiers not always completed at the time of submission. ANSES can accept that final reports be sumitted during the evaluation but this should be discussed on a case by case basis during pre-submission meetings

No stop of the clock foreseen in the procedure for RMS to request additionnal information during assessment while it is most of the time necessary

As requested by Reg. 1107/2009, applicants shall provide in their dossier a review of the scientific open literature according to the EFSA GD (EFSA Journal 2011; 9(2):2092). However, this is not always exhaustive or done properly

Some lack of predictability during pre-submission meetings on the availability/use of some technical GD (e.g. operator or bees GD) which should apply at the time of submission of the dossier

Cut Off criteria apply but are not always clearly defined (e.g. interim criteria for ED)

Difficulties and Challenges with AIR III

Conclusion

Conclusion

AIR III procedures and timelines are clearly defined

However these short timelines and workload are really challenging especially for dossiers submitted in 2014 and 2015

And these challenges and difficulties increase when:Several applicants submit separate dossiers

Number of representative uses and/or PPP are high

CLH report shall also be prepared in the same time

Major issues are raised by the RMS during the evaluation Difficulties to finalise the evaluation within the timelines

Anyway, we keep working and smiling…

Thank you !!!